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临床试验/NCT04817124
NCT04817124已完成不适用

Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-based Context

University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Feasibility of conducting the intervention in a home-based context

研究概览

简要总结

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training is feasible as a home-based intervention.

详细描述

The goal of the present study is to assess feasibility (primary) and cognitive training and transfer effects of a home-based multi-session cognitive training combined with transcranial direct current stimulation (tDCS). tDCS, particularly in combination with cognitive training, represents a promising approach to counteract cognitive decline and restore impaired functions. However, combined interventions of cognitive training and tDCS involve frequent visits to the facility, which leads to the need of space, time and personnel, and imposes strains on the participants. This study will elucidate the feasibility of tDCS and cognitive training in a home-based context. Healthy older adults will participate in a two-week cognitive training with concurrent online tDCS application in their own homes. Feasibility, as well as cognitive performance will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. We hypothesize that with appropriate training of the participants and close supervision the use of combined tDCS and cognitive training in an ecologically valid environment by the participants themselves is feasible. In addition, we hypothesize this protocol will lead to improved performance on the trained tasks in both experimental groups. We expect increased performance on transfer tasks and long-term maintenance of the effects after anodal compared to sham stimulation. A successful implementation of the intervention in the home-based setting will contribute to the development of home-based tDCS as a widely available therapy option in clinical populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 60 - 80 years
  • Right handedness

排除标准

  • Neurodegenerative neurological illnesses, epilepsy or history of seizures
  • Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician
  • History of severe alcoholism or use of drugs
  • Severe psychiatric disorders such as depression (if not in remission) or psychosis
  • Contraindication to tDCS application

结局指标

主要结局

Feasibility of conducting the intervention in a home-based context

时间窗: 2 weeks

Feasibility of home-based tDCS as operationalized by at least 2/3 (out of 6 planned sessions) successfully performed interventional sessions per participant. A session is regarded as successful if it is marked as completed in the stimulation system.

次要结局

  • Working memory performance at follow-up assessment(4 weeks after intervention)
  • Working memory training performance (Letter Updating Task) at follow-up assessment(4 weeks after intervention)
  • Feasibility (questionnaire)(2 weeks)
  • Working memory performance at post-assessment(2 weeks)
  • Working memory training performance (Letter Updating Task) at post-assessment(2 weeks)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (1)

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